Type 2 Diabetes Mellitus Clinical Trial
Official title:
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Forxiga in Patients With Type 2 Diabetes in Korea
This surveillance is a postmarketing commitment following the marketing authorization for Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified by the MFDS under Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.
Protocol Title: Forxiga (dapagliflozin) Regulatory Postmarketing Surveillance
Department: Korea Medical
Objective(s): The primary objective of this study is to examine the safety profiles of
Forxiga in Korean patients with T2DM.
The secondary objective of this study is to examine the effectiveness profiles of Forxiga in
Korean patient with T2DM.
The exploratory objective of this study is to identify factors that might be associated with
the safety and effectiveness profiles of Forxiga in Korean patient with T2DM.
Study Design: This is a local, prospective, noninterventional, regulatory postmarketing
surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Forxiga
as indicated by the Ministry of Food and Drug Safety (MFDS) will be included. Patients will
be followed for a minimum of 12 weeks or a minimum 24 weeks. Patients will be treated as part
of routine practice at Korean healthcare centers by accredited physicians. In this study,
patients will receive 10 mg or 5 mg of Forxiga in conjunction with diet and exercise
modifications for the treatment of T2DM.
Study Population: Physicians should enroll adult patients who are diagnosed with T2DM and who
initiate treatment with 10 mg of Forxiga, or 5 mg of Forxiga in patients with severe hepatic
impairment as a starting dose, for the first time.
Data Collection Methods: and Astra-Zeneca will select medical institutions including relevant
departments, such as internal medicine and family medicine, of university hospitals, general
hospitals and clinics where the surveillance drug is mainly prescribed and where staff can
sufficiently fulfill the objectives of the surveillance and request for surveillance after
signing a written contract. Patients' medical records will be data sources in this study.
Only if the laboratory test is done as part of standard of care practice and the data are
available will the data be collected for this study.
Data Analyses: Statistical analyses will be of explorative and descriptive nature. All
analyses will be performed for the total study population who will consist of all patients
taking at least one dose of Forxiga. For the safety assessment, occurrences of adverse events
(AEs), serious adverse events, adverse drug reactions (ADR), and unexpected adverse drug
reactions will be calculated. Severity, actions taken to the surveillance drug, outcome, and
causal relationship of AE to the study drug will be analyzed. At the time of the regular
reporting and the final reporting, the event count, incidence proportion (that is, the number
of patients with any events divided by the number of patients) and incidence rate (number of
patients with any events divided by the duration of time patients are followed up in the
study) of all the adverse events surveyed during the re-examination period will be
summarized, and 95% confidence interval will be presented. Changes in Hemoglobin A1c(HbA1c),
Fasting plasma glucose(FPG), and Post-prandial glucose-2 hour(2-hr PPG) before and after
administration of Forxiga will be analyzed. At the time of the regular reporting and the
final reporting, the event count and effectiveness rate of improvement of lab result (HbA1c,
FPG, and PPG), surveyed during the re-examination period will be summarized, and 95%
confidence interval will be presented. In order to explore the factors that might influence
safety and effectiveness profiles, the cumulative incidence proportion of adverse events and
effectiveness rate will be analyzed by patients' background characteristics Sample
Size/Power: In accordance with the guidelines provided by the MFDS, at least 3,000 patients
will be enrolled. For the overall study population of approximately 3000 patients, the
incidence proportion of infrequent adverse events(for example, an incidence proportion of
0.1%) can be estimated with a 95% CI of (0.02, 0.29) (n=3 patients with events).
Limitations/Strengths: The surveillance, with characteristics of a noninterventional,
observation study, has no control group and will follow patients in usual clinical practice.
Given these conditions, the types of safety and effectiveness data available for collection
may be limited compared with other noninterventional clinical trials. This surveillance study
will generate results from a wider range of data than those previously derived from the more
limited clinical trial setting and will allow for longer follow up among a more varied
patient population.
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